IMA freeze dry

IMA Freeze dryer

Freeze drying – or lyophilization – is a process that removes water from a product at low temperatures. First, the substance is frozen. It is then dried by sublimation of ice under vacuum pressure. This is done without damaging or changing the product. It is a sensitive process that requires the highest level of protection. Freeze drying is a much gentler way of dehydrating a substance than other methods that require high temperatures. High temperatures risk destroying or changing the product.

A freeze-dried product can easily be rehydrated again by adding water. Freeze drying also significantly extends shelf life. This makes the method particularly applicable for a large number of products in the pharmaceutical and biotech industry.

Together with IMA, PPS supplies containment freeze drying equipment as well as freeze dryers for lab scale and production purposes. Additionally, we offer filling, loading and unloading equipment, also from IMA, offering the benefit of the entire freeze dryer solution coming from the same supplier.

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IMA LYNFINITY

IMA LYNFINITY Continuous Aseptic Spray-Freezy-Drying

Raising productivity and reducing downtime is now possible in a continuous aseptic process, with constant monitoring from fermentation to final packaging.

LYNFINITY spray-freeze-drying process features a controlled spray of liquid product into a cryogenically cooled freezing chamber. The resultant frozen particles of the liquid product are freeze-dried in the drying module. The drying chamber contents are both transported and heated to promote rapid sublimation and prevent agglomeration.

The continuous spray-freeze-drying process starts with bulk liquid product and ends with the discharge of dried particles, featuring total containment from formulation to powder filling. This enables higher sterility assurance levels, whereas traditional freeze-drying requires additional external material handling, for example during filling. Upon completion of drying, the uniform, dried spherical product allows for the use of a variety of containers (vials, syringes, inhalation systems etc.).

  • Designed for continuous process from fermentation to final packaging
  • Greater throughput flexibility: minimization of scale up and scale down challenges
  • Better quality attributes: improved product uniformity through a gentle drying process
IMA LYOMAX

IMA LYOMAX Industrial Freeze Dryer

Freeze-drying involves removal of solvent such that the molecular structure of the active ingredient of the drug is least disturbed, thus providing a dried drug product that is stable over time.

Although one of the oldest techniques in the pharmaceutical industry for the preservation of unstable materials, there has been an increasing demand for lyophilized products and equipment, in particular in the last decade. In fact today, about half of all sterile injectables are lyophilized.

The freeze-drying process of today demands increased process control, with reduced processing time augmented with upgrades in equipment to remain compliant with a changing regulatory landscape. To accommodate such growth, IMA LIFE uses its in-depth process knowledge to make freeze drying faster, safer, cheaper, and compatible with all industry requirements and challenges.

LYOMAX configurable options and custom designs provide the optimal solution for each application. IMA LYOMAX meets the highest possible technical requirements, the strictest standards of the global licensing authorities, and comply with all the current guidelines such as GAMP, cGMP, FDA etc.

  • Machine sizes from 1 m2 to 100 m2.
  • Configurations including integral condenser, external condenser, two-story and pass through designs.
  • Two stage reciprocating semi-hermetic/screw compressors/liquid nitrogen refrigeration system.
IMA MINIMAX

IMA MINIMAX Small-scale Freezy Dryer

Based on the successful LYOMAX industrial FD concept, MINIMAX is a GMP, small-scale freeze dryer developed to address the demands involved in handling small production batches.

The IMA MINIMAX series provides scalable lyophilization technologies from formulation to full commercial production. Process analytical technologies (PAT) also help manufacturers to find desirable conditions and parameters for perfect drying outcomes. Pilot-scale freeze drying is the optimal solution for scale up operation volumes prior to industrial scale production or even for small production batches. The aim is to achieve drug commercialisation objectives and bring parenteral products safely and quickly to market by enhancing product and process knowledge. This ensures superior product quality and uniformity and creates a data-rich environment ensuring successful operation of all freeze-drying system sizes.

MINIMAX benefits from all-round performance, a high level of redundancy and various configurable options making it a reliable and versatile solution for each application. MINIMAX can be integrated with isolation technology and automatic vial-loading systems. The unit is pre-arranged to support the processing of non-aqueous solvents and high potent products.

  • Available in six configurations with shelf areas from 1.0 up to 3.9 m2
  • CIP-SIP included
  • Ice condenser capacity ranging from 29 to 78 kg with minimum condenser temperatures of – 75°C.
IMA LYOFAST

IMA LYOFAST Industrial Freeze Dryer

Freeze-drying of biopharmaceuticals has become a routine procedure, which leads to an increase in product stability. LYOFAST is the pre-engineered cost-effective, reliable and efficient standard solution.

The freeze drying process has important applications in the pharmaceutical and biotechnology industries, and pharmaceutical freeze drying is now a standard process used to stabilize, store or increase the shelf life of drug products and other biologicals.

LYOFAST is IMA Life solution to keep freeze-drying competitive as a pharmaceutical processing step.

For either bulk format or liquid in vials, ampoules or syringes, the LYOFAST units are designed for freeze drying high value products, such as: vaccines, antibiotics, cytostatics, biologicals, hormones, active ingredients, and reactives.

  • Freeze drying areas from 4 m2 to 50 m2.
  • Cylindrical or rectangular chamber with separate ice condenser.
  • Two stage reciprocating semi-hermetic, water-cooled refrigeration system.
IMA LYOFAST MINI

IMA LYOFAST MINI Pilot Freeze Dryer

The new compact LYOFAST MINI range of freeze dryers provides the link between laboratory development, pilot and industrialized production.

Because the cost of the specialized equipment required for freeze drying can be substantial, the process may appear to be an expensive undertaking. However, savings realized by stabilizing an otherwise unstable product at ambient temperatures, thus eliminating the need for refrigeration, more than compensate for the investment in freeze drying equipment.

Freeze drying of the initial scale up batches provides an opportunity to test the robustness of the process, to understand the future technology requirements for industrial production, and to optimize the process, thus reducing the energy requirement and downstream production costs, adding commercial value to your product.

To cope with market drivers, IMA LYOFAST MINI series of freeze dryers have been developed to be suitable for the following applications: product development and process cycle optimization, up scaling of the process for later use in production plants and small-scale production especially for biotech customers.

  • Four different configurations available, from 1 to 2.8 m2.
  • CIP-SIP included.
  • Slot door suitable for RABS/isolator integration.
IMA MINIFAST

IMA MINIFAST Pilot Freeze Dryer

The MINIFAST range of freeze dryers is the connecting factor between a typical bench-top freeze dryer used in the laboratories and the GMP production scale ones.

Freeze-drying technology comes in all sizes and MINIFAST is the ideal size for R&D requirements of a laboratory environment. MINIFAST is a laboratory solution designed according to the same technical performance and quality standards as a production-scale lyophiliser.

The product is available in MINIFAST 04 and MINIFAST 10 configurations, with shelf areas of 0.4 and 1.1 m2.

Product shelves are designed and manufactured using the IMA Life patented FUSION™ design to enhance performance, reduce operating costs and increase reliability.

  • Pilot scale for R&D and small production batches.
  • Rectangular chamber in AISI 304L.
  • Shelf areas available from 0.4 m2 and 1.1 m2.
PPS A/S Service & Aftersales solutions for customers

PPS Service & Aftersales

Uniquely for the industry PPS has its own service department, which is of great benefit to our customers. PPS service department has specially trained technicians with the highest expertise and experience. We offer a long list of services, including:

  • Installation and renovation of existing equipment.
  • Design of complete solutions; everything from the requirements specifications and logistics, to execution and validation.
  • Competent feedback on automation solutions or other type of production optimization.
  • Installing and/or moving entire production or packaging lines.
  • Training of technical personnel and operators in optimal use of the installed equipment.
  • Tailor-made service and aftersales agreements for ongoing maintenance as well as assistance in case of breakdown.

In addition, PPS delivers spare parts and consumables directly to our customers from own stock. Having our own stock ensures fast and efficient delivery, which minimizes any production downtime for our customers.

If you want to know more about our service department, please contact us directly or get more information here.